Over-the-counter drug · ANDA
cetirizine hydrochloride (Cetirizine hydrochloride tablets) NDC 70677-1007
Cetirizine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Strategic Sourcing Services LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)70677-1007Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70677-1007Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70677-1007-2 | 7067710070270677100702 | 1 BOTTLE in 1 CARTON (70677-1007-2) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from May 5, 2023 | |
| 70677-1007-3 | 7067710070370677100703 | 1 BOTTLE in 1 CARTON (70677-1007-3) / 90 TABLET, FILM COATED in 1 BOTTLEMarketed from May 5, 2023 | |
| 70677-1007-4 | 7067710070470677100704 | 1 BOTTLE in 1 CARTON (70677-1007-4) / 300 TABLET, FILM COATED in 1 BOTTLEMarketed from May 5, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- cetirizine hydrochloride
- Generic name (nonproprietary)
- cetirizine hydrochloride tablets
- Active ingredients
- Cetirizine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Strategic Sourcing Services LLCNDC labeler code 70677
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078343
- Marketing start
- Marketing end
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 70677-1007_b13a3e2a-c087-727c-8d9e-90faa85292e6SPL ID b13a3e2a-c087-727c-8d9e-90faa85292e6SPL set ID 52b70885-f623-b1c8-29c6-584bff46ed45RxCUI 1014678UNII 64O047KTOA
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470677100702followed by a unit qualifier and the quantityPackage 70677-1007-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat .
Excerpt only. Read the full label for complete information.
About NDC 70677-1007
- What is NDC 70677-1007?
- 70677-1007 is the product NDC for cetirizine hydrochloride (cetirizine hydrochloride tablets), Cetirizine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Strategic Sourcing Services LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- cetirizine hydrochloride (Cetirizine Hydrochloride Tablets).
- What is the active ingredient?
- Cetirizine hydrochloride.
- Who is the labeler?
- Strategic Sourcing Services LLC, NDC labeler code 70677. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for cetirizine hydrochloride?
- 107 other product NDCs are listed under this name. See all cetirizine hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other cetirizine hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 5 mg/1 | TabletOral | First Nation Group, LLC | 81469-352 | 81469-0352-01 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | TabletOral | First Nation Group, LLC | 81469-353 | 81469-0353-0181469-0353-0381469-0353-05+1 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-017 | 48433-0017-20 |
| Cetirizine hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Advagen Pharma Ltd., | 72888-480 | 72888-0480-01 |
| cetirizine hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-4072 | 68788-4072-0368788-4072-0668788-4072-09 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Bionpharma Inc. | 69452-426 | 69452-0426-5569452-0426-88 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-357 | 57237-0357-1257237-0357-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-358 | 57237-0358-1257237-0358-24 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-2261037-0480-2361037-0480-24+2 more |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 1 mg/mL | SolutionOral | BAJAJ MEDICAL, LLC | 61037-480 | 61037-0480-0261037-0480-0361037-0480-04+2 more |
Other NDCs under ANDA 078343
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Discount Drug Mart, Inc | 53943-519 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-699 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | VERITYRX, LLC | 83939-0004 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Sportpharm LLC | 85766-045 |
| Cetirizine Hydrochloride | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr.Reddy's Laboratories Limited | 55111-351 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-183 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Laboratories Inc. | 43598-811 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 71205-709 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9612 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-801 |
| Cetirizine Hydrochloridecetirizine hydrochloride tablets | Cetirizine hydrochloride 10 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8435 |